NCT06939673

Study of Miro3D Wound Matrix for Healing Wounds and Ulcers in Outpatient Care

Recruiting now NA Last updated 24 December 2025

What this trial tests

NA trial testing Acellular Porcine-Derived Wound Matrix in Diabetic Foot Ulcers (DFUs) in 20 participants. Currently enrolling.

Timeline

29 February 2024

Primary endpoint
31 December 2025

31 December 2025

Quick facts

Lead sponsor	Reprise Biomedical, Inc.
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	20
Start date	29 February 2024
Primary completion	31 December 2025
Estimated completion	31 December 2025
Sites	2 locations across United States

Drugs / interventions tested

• Acellular Porcine-Derived Wound Matrix

Conditions studied

• Diabetic Foot Ulcers (DFUs) — all drugs for Diabetic Foot Ulcers (DFUs) →
• Venous Leg Ulcers (VLUs) — all drugs for Venous Leg Ulcers (VLUs) →
• Pressure Ulcers — all drugs for Pressure Ulcers →
• Surgical Wound Dehiscence (SWD) — all drugs for Surgical Wound Dehiscence (SWD) →

Sponsor

Reprise Biomedical, Inc.

Who can join

18 and older, any sex, with Diabetic Foot Ulcers (DFUs) or Venous Leg Ulcers (VLUs). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This clinical study is being conducted to evaluate how well the Miro3D Wound Matrix helps heal difficult wounds and ulcerations in an outpatient care setting. Miro3D is a biologic wound dressing made from porcine (pig) liver tissue. It is processed to remove all cells, creating a clean scaffold that can support the body's natural healing process. The goal of this study is to see how effective Miro3D is when used alongside standard wound care for helping wounds close and reducing pain and discomfort.

The study is designed as a post-market, proof-of-concept trial, meaning the product is already commercially available, and researchers are evaluating how it works in real-world clinical settings. A total of up to 20 adult participants will be enrolled. Participants may have wounds such as diabetic foot ulcers, venous leg ulcers, pressure ulcers, or surgical wound dehiscence. These wounds may be complex in nature, including tunneling or undermining, which often makes them more difficult to treat.

Participants will receive standard wound care along with weekly Miro3D applications for the first 4 weeks. If the wound is not fully healed after 4 weeks, Miro3D will then be applied every 2 weeks until healing is achieved or up to 12 weeks total. Throughout the study, participants will return weekly for wound assessments and to complete brief questionnaires about their pain levels and quality of life.

The main goals of the study are:

1. To measure how much the wound size shrinks (known as percent area reduction or PAR).
2. To evaluate how much healthy granulation tissue (new tissue) forms in the wound.
3. To compare healing outcomes when Miro3D is used weekly versus every two weeks.
4. To understand how the treatment affects patients' quality of life, including pain, mobility, and emotional wellbeing.

Each participant will be closely monitored by the clinical team throughout the 12-week study period. If a wound heals earlier, the participant will finish the study at that time. If the wound does not heal, the participant may return to their regular physician for follow-up care.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Immunomodulatory Mechanisms of Chronic Wound Healing: Translational and Clinical Relevance.
   Riaz M, Iqbal MZ, Klar AS, Biedermann T. · · 2025 · cited 1× · PMID 41127507 · DOI 10.1002/mco2.70378